Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Allowable Subject Matter
Claims 25, 26, and 47 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art fails to teach or disclose wherein the method includes translating BMI (Body Mass Index) to intravaginal pressure for the vaginal canal model, determining distances of ischial spines to each other and to pubis and coccyx, and determining a reaction force, and its direction, based on the distances.
The prior art fails to teach or disclose wherein adjusting the geometry of the gynecological prosthetic comprises performing a parametric study to determine a topologically suitable design for the gynecological prosthetic and performing a topology optimization to reduce weight of the gynecological prosthetic without compromising functionality.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 22-24, 27-30, and 37-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Pub. No. 2020/0214617 to Sham.
As to Claim 22, Sham discloses a method (1100, Fig. 11) of custom-designing a gynecological prosthetic [0274]. The method comprises acquiring, by a processor, patient data pertaining to a subject (1100, [0276-0281]), selecting the gynecological prosthetic out of a plurality of pre-defined gynecological prosthetics [0286-0293, 0304-0305], wherein each pre-defined gynecological prosthetic is configured to expand differently and in different directions based on received pressure from surrounding tissues and organs [0288-0290], and calculating (1134), by a processor, geometry of the gynecological prosthetic that has been selected based on the patient data that has been acquired [0297-0298].
As to Claim 23, Sham discloses a method further comprising maintaining pre-clinical data, wherein the selecting and the calculating steps are based on both the pre-clinical data and the patient data [0276-0281, 0304].
As to Claim 24, Sham discloses a method further comprising generating a vaginal canal model based on the patient data [0161], and simulating the gynecological prosthetic in the vaginal canal model to evaluate suitability of the gynecological prosthetic in accordance with a target function [0294], wherein calculating the geometry of the gynecological prosthetic comprises adjusting the geometry material of the gynecological prosthetic to enhance the suitability of the gynecological prosthetic based on the target function [0297].
As to Claim 27, Sham discloses a method wherein the patient data comprises a cervical angle and/or data from which the cervical angle can be determined [0129-0137, 0139].
As to Claim 28, Sham discloses a method wherein the patient data comprises intra-abdominal pressure [0090].
As to Claim 29, Sham discloses a method wherein the patient data comprises total vaginal length [0136], wherein the patient data is acquired by a caliper tool [0138].
As to Claim 30, Sham discloses a method wherein the geometry of the gynecological prosthetic comprises a gynecological prosthetic length [0254].
As to Claim 37, Sham discloses a method further comprising manufacturing the gynecological prosthetic [0335].
As to Claim 38, Sham discloses a method wherein the manufacturing the gynecological prosthetic comprises 3D printing the gynecological prosthetic [0108, 0335].
As to Claim 39, Sham discloses a method wherein the manufacturing the gynecological prosthetic comprises 3D printing a mold of the gynecological prosthetic [0335].
As to Claim 40, Sham discloses a method wherein the gynecological prosthetic comprises at least two polymers [0333] and the manufacturing the gynecological prosthetic comprises combining the at least two polymers [0333].
As to Claim 41, Sham discloses a method further comprising coating the gynecological prosthetic [0335].
As to Claim 42, Sham discloses a method wherein the gynecological prosthetic is configured to be expandable from a compact state [0308].
As to Claim 43, Sham discloses a method wherein the gynecological prosthetic is configured to expand differently in different directions when expanding from the compact state [0308].
As to Claim 44, Sham discloses a method wherein the gynecological prosthetic comprises a plurality of anchor members configured to rest on anchor points within a vagina [0182, 0184, 0297, 0319].
As to Claim 45, Sham discloses a method wherein the target function is based on a pre-defined criteria [0294].
As to Claim 46, Sham discloses a method wherein the simulating the gynecological prosthetic in the vaginal canal model to evaluate suitability of the gynecological prosthetic in accordance with the target function comprises iteratively simulating the gynecological prosthetic in the vaginal canal model [0161, 0294, 0297].
Conclusion
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/CHRISTOPHER J BECCIA/Primary Examiner, Art Unit 3775
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